510(k) · Cleared
ClearedMon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · FLL Continuous Measurement Thermometer
Cleared on Aug 20, 2024 as substantially equivalent to K874514 (Mallinckrodt Critical Care, 1988) after a 223-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Aug 20, 2024
- Review
- 223 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874514 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK874514 HI-LO Temp (R) General Purpose Temperature ProbeMallinckrodt Critical Care · 1988
- This deviceK240077 Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)Covidien · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874514 | HI-LO Temp (R) General Purpose Temperature Probe | Mallinckrodt Critical Care | 1988 | — |
| 0 (this device) | K240077 | Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) | Covidien | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K874514 | HI-LO Temp (R) General Purpose Temperature ProbeSummary page 5…TE DEVICE Predicate Manufacturer: Mallinckrodt Critical Care Predicate Trade Name: Hi-Lo Temp® General Purpose Temperature Probe Predicate 510(k): K874514 Covidien llc… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Mon‑a‑Therm™ General Purpose Temperature Probe 400TM is indicated for use in the routine monitoring of temperature in an anesthetized patient. The device is intended primarily for insertion into the esophagus or rectum, although medical judgment may dictate the selection of other anatomical sites such as the nasopharynx for some patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240077: Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240077
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026